Field of Invention
The invention related to the apparatus and method of safely inserting a prosthesis into a human body.
Background of the Invention
The present invention is a useful and novel apparatus for assisting a surgeon in avoiding complications during a prosthesis implant surgery, such as a breast implant.
Breast implants are a manufactured prosthesis used in cosmetic and reconstructive surgery. A breast implant is gelatinous, having an outer casing or membrane and an inner fluid substance such as saline or silicone.
Most implant procedures today do not use an insertion device. The surgeon makes the incision, creates a pocket for the implant, retracts the incision and then manually pushes the implant into the pocket. A saline implant can be inserted into a pocket in an empty configuration; once in place in the pocket, the implant is then filled with saline solution.
Preferably, the incision in the patient is as short as possible. Shorter incisions are less unsightly. This goal of a shorter incision is easier to accomplish with a saline implant. A saline implant is relatively easy to insert through a short incision, as the bladder is unfilled and therefore small in size as it passes through the incision. In contrast, silicone implants are prefilled resulting in a more difficult and complications-susceptible operation.
The incision is made in one of four places: under the arm, in the breast fold, in the belly button, or around the nipple. Except for the belly button insertion, one incision is made for each implant. Next, the surgeon cuts a path through the tissue to the desired destination of the implant. Once that path has been created, the tissue and muscle must be separated to create a pocket, or cavity, for the implant.
The pocket may be formed in one of two places under the breast: subglandular (between the breast tissue and pectoralis major muscle) or subpectoral (under the pectoralis major muscle). Subglandular places the prosthesis directly behind the mammary gland and in front of the muscle. Subpectoral places the implant partially under the pectoralis major muscle. Due to the structure of the pectoralis major, a portion of the implant is not covered by the pectoralis.
For inflatable implants, the surgeon rolls up the implant like a cigar and pushes it through the incision and into the pocket. The surgeon then uses a tube to fill the implant with saline.
For pre-filled implants, the procedure requires a larger incision length. The implant is then manually pushed through the incision into the pocket.
Risks to patients receiving breast implants include additional surgeries to change the placement (from subglandular to subpectoral or visa versa), or to correct folding, rupture; infection; breast pain; contracted scar tissue forming around the implant; and collections of fluids around the implant. The overall complication rate is about 25% for silicone gel breast augmentation with the majority of re-operations related to implant rupture, leak or capsular contracture.
Infection, or Cellulitis, occurs in 2%-4% of patients, with some surgeons reporting much higher rates, and is usually from the bacteria normally present on the skin. Symptoms of infection include fever, pain, swelling and redness. To reduce infection, surgeons give a single dose of antibiotics before the surgery, and use an antibiotic solution in the wound before implant placement. The antibiotic solution may double as lubrication to allow easier insertion of the implant into the pocket. However, surgeons can bring the rate of infection down further by eliminating the chance the prosthesis touches the skin. This “no touch” technique can be improved with universal bellows of the present invention.
The implant insertion devices heretofore known suffer from a number of disadvantages:                1. Difficult to handle in a lubricious state.        2. Difficult to maintain position of insertion device in the incision.        3. Difficult to manage the speed of the insertion through the proximal end of the insertion device into the pocket.        4. Have no control over external pressure applied to implant.        5. Requires the surgeon to resize the insertion device to match different implant sizes.        6. Allow the implant to come in contact with a reusable retractor which has microscopic irregularities and/or sharp edges.        7. Due to the high cost, encourage re-use despite manufacturer recommendation not do so.        